RecruitingPhase 4NCT06602622

Change in Body Weight and BMI in PWH with DOR/3TC/TDF Compared with INSTI

Change in Body Weight and BMI in PWH Virologically Suppressed Who Maintain a Second-generation INSTI Regimen Compared to Those Who Switch to DOR/3TC/TDF At 48 Weeks

Sponsor

Instituto Mexicano del Seguro Social

Enrollment

108 participants

Start Date

Aug 14, 2024

Study Type

INTERVENTIONAL

Conditions

Weight Loss HIV-1-infection HIV Weight Change HIV Associate Weight Loss Integrase Inhibitors, HIV; HIV PROTEASE INHIB

Summary

Patients who developed metabolic syndrome after initiation of HIV treatment or with antiretroviral therapy (ART) for at least 36 months, treated with second generation integrase inhibitors (BIC/TAF/FTC, DTG/ABC/3Tc or DTG+TDF/FTC) who have gained at least 10% of their total body weight after starting ART, with a body mass index ≥25 kg/m2 and body fat greater than 20% will be eligible to participate in this clinical trial. If they decide to participate, they will sign an informed consent. After this, a mobile application will randomly decide whether the participant will continue with their ART regimen or switch to another ART (listed in the guidelines as one of the main lines of treatment) containing doravirine/lamivudine/disoproxil fumarate tenofovir. Medical visits will be at 1 month, 3 months, 6 months, 9 months, and 12 months after get in to this protocol, with laboratory studies that evaluate fats, blood sugar, liver function, kidney function, and test for HIV control; in addition, each visit will be given self-fillable scales to evaluate neuropsychiatric disorders such as depression, anxiety, insomnia, satisfaction with treatment or symptoms associated with it.The aim of the study is to observe whether there is weight loss with the change in HIV treatment.

Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 80 Years

Inclusion Criteria14

Virologically suppressed for at least 48 weeks prior to study entry
Coming from a regimen containing Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF), Dolutegravir/Lamivudine/Abacavir (DTG/3TC/ABC), or, Dolutegravir/Tenofovir Disoproxil Fumarate/Emtricitabine (DTG+TDF/FTC) with no known failures to integrase inhibitors for al least 48 weeks.
BMI ≥25 kg/m2 at screening and
Unintentional weight gain of \>10% from baseline (prior to INSTI initiation) within 1-3 years of starting INSTI ART, with no other apparent medical reason to explain the weight gain (concomitant medication use, Cushing's disease, recent prolonged hospitalization, etc.), in the opinion of the site investigator.
Body fat percentage \>20%
No indication or plans to add or change medications associated with significant weight change during the study period.
Participants currently receiving antipsychotics, antidepressants, anticonvulsants/mood stabilizers, and thyroid replacement hormones without dose modifications for at least 12 weeks prior to randomization
Participants currently receiving antidiabetics known to cause weight loss and without dose modifications for at least 24 weeks prior to randomization (GLP-1 receptor agonists, SGLT-2 inhibitors, insulin, metformin).
Agree to adhere to assigned ART during the study period
HIV-1 RNA screening \<50 copies/mL performed within 45 days prior to study entry.
GFR by CDK-EPI ≥60 mL/min
Alanine aminotransferase (ALT) and asparatate aminotransferase (AST) \< 90 IU/L
Thyroid profile (TSH, free T3 and free T4) prior to entering the study
Serum and urinary electrolytes, cystatin C, prior to entering the study

Exclusion Criteria10

Loss of social security
Allergy to any of the components of ART, previously unknown.
Withdrawal of informed consent
Acquiring HBV and/or HCV infection during follow-up.
HIV-1 RNA \>200 copies/mL in 2 consecutive determinations after having achieved virological suppression.
Early initiation or discontinuation of any of the following drugs after entering the study: antipsychotics (clozapine, olanzapine, risperidone); antidepressants (tricyclic antidepressants, selective serotonin reuptake inhibitors) monoamine oxidase inhibitors, associated with weight gain; anticonvulsants/mood stabilizers (lithium, valproic acid) or associated with weight loss (topiramate); thyroid replacement hormones;
Change in dose or discontinuation of antidiabetic drugs that cause weight loss (GLP-1 receptor agonists, SGLT-2 inhibitors, insulin, metformin), after entering the study.
Planning to undergo or having undergone bariatric surgery.
Initiating significant dietary changes, advised by a nutritionist according to what was reported by the participant
Initiating or increasing physical exercise or enrolling in a structured weight loss regimen: \<250 minutes/week of moderate to intense activity

Interventions

DRUGIntegrase inhibitor

Second generation integrase inhibitor 1) Bictegravir 50 mg/ alafenamide tenofovir 25 mg/ emtricitabine 200 mg (BIC/TAF/FTC); 2) Dolutegravir 50 mg/ abacavir 600 mg/ lamivudine 300 mg (DTG/ABC/3TC); 3) DTG 50mg+TDF 300mg/FTC 200mg (DTG+TDF/FTC) Each will be prescribed one tablet every day during 48 weeks

DRUGDoravirine + tenofovir DF + lamivudine

Individuals who meet the selection criteria will be randomized to maintain their same regimen with second-generation integrase inhibitors or switch to DOR/TDF/3TC 100/ 300/300 mg It will be prescribed one tablet every day during 48 weeks